Farxiga, Forxiga(dapagliflozin)
Dapagliflozin, Ebymect, Edistride, Farxiga, Forxiga, Qtern, Qternmet, Qtrilmet, Xigduo (dapagliflozin) is a small molecule pharmaceutical. Dapagliflozin was first approved as Forxiga on 2012-11-11. It is used to treat type 2 diabetes mellitus in the USA. It has been approved in Europe to treat chronic renal insufficiency, diabetes mellitus, glucose metabolism disorders, heart failure, and metabolic diseases amongst others.
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Commercial
Trade Name
FDA
EMA
Farxiga (discontinued: Dapagliflozin)
CombinationsQtern, Xigduo (discontinued: Qternmet)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dapagliflozin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FARXIGA | AstraZeneca | N-202293 RX | 2014-01-08 | 2 products, RLD, RS |
Dapagliflozin
+
Saxagliptin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| QTERN | AstraZeneca | N-209091 RX | 2017-02-27 | 2 products, RLD, RS |
Dapagliflozin
+
Metformin hydrochloride
+
Saxagliptin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| QTERNMET XR | AstraZeneca | N-210874 DISCN | 2019-05-02 | 4 products, RLD |
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Dapagliflozin
+
Metformin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XIGDUO XR | AstraZeneca | N-205649 RX | 2014-10-29 | 5 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dapagliflozin | NDA authorized generic | 2024-10-24 |
| dapagliflozin and metformin hydrochloride | NDA authorized generic | 2024-12-20 |
| farxiga | New Drug Application | 2024-10-24 |
| qtern | New Drug Application | 2024-11-13 |
| xigduo | New Drug Application | 2024-12-20 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| type 2 diabetes mellitus | EFO_0001360 | D003924 | E11 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DAPAGLIFLOZIN, FARXIGA, ASTRAZENECA AB | |||
| 2024-04-30 | I-857 | ||
| 2023-05-05 | I-834 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Dapagliflozin, Farxiga, Astrazeneca Ab | |||
| 10973836 | 2040-03-09 | U-3127 | |
| 8685934 | 2030-05-26 | U-1522 | |
| 8721615 | 2030-01-18 | DP | |
| 7919598 | 2029-12-16 | DP | |
| 7851502 | 2028-08-19 | DP | |
| 8221786 | 2028-03-21 | DP | |
| 8361972 | 2028-03-21 | U-493, U-1976, U-1977, U-2139 | |
| 8716251 | 2028-03-21 | DP | |
| 8501698 | 2027-06-20 | DP | U-493, U-1976, U-1977 |
| 8329648 | 2026-08-18 | U-2139, U-2212, U-2213 | |
| 8906851 | 2026-08-18 | U-2139 | |
| 6515117 | 2025-10-04 | DS, DP | U-493, U-2139 |
| 7456254 | 2025-06-30 | DP | U-2139 |
| 8431685 | 2025-04-13 | DP | U-2139 |
| 8461105 | 2025-04-13 | DP | U-2139 |
| 9238076 | 2024-04-15 | DP | U-2139 |
| Dapagliflozin / Metformin Hydrochloride, Xigduo Xr, Astrazeneca Ab | |||
| 9616028 | 2030-11-12 | DP | |
| Dapagliflozin / Metformin Hydrochloride / Saxagliptin Hydrochloride, Qternmet Xr, Astrazeneca Ab | |||
| 8628799 | 2025-07-13 | DP | |
| RE44186 | 2023-07-31 | DS, DP | U-493 |
ATC Codes
A: Alimentary tract and metabolism drugs
— A10: Drugs used in diabetes
— A10B: Blood glucose lowering drugs, excl. insulins
— A10BD: Combinations of oral blood glucose lowering drugs
— A10BD15: Metformin and dapagliflozin
— A10BD21: Saxagliptin and dapagliflozin
— A10BD25: Metformin, saxagliptin and dapagliflozin
— A10BK: Sodium-glucose co-transporter 2 (sglt2) inhibitors
— A10BK01: Dapagliflozin
HCPCS
No data
Clinical
Clinical Trials
629 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 22 | 9 | 40 | 35 | 20 | 122 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 5 | 8 | 35 | 27 | 13 | 85 |
| Heart failure | D006333 | EFO_0003144 | I50 | 2 | 2 | 9 | 3 | 8 | 24 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 9 | 6 | 2 | 5 | 22 |
| Chronic renal insufficiency | D051436 | — | N18 | 1 | 9 | 6 | 2 | 4 | 21 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 2 | 6 | 1 | — | 8 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 2 | 1 | 3 | 1 | 1 | 8 |
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | 3 | 1 | 2 | — | 5 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 2 | 2 | 1 | — | 5 |
| Renal insufficiency | D051437 | — | N19 | 1 | 1 | 1 | 2 | — | 5 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Body weight | D001835 | EFO_0004338 | — | — | 3 | 1 | — | — | 4 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | — | 1 | — | — | 1 |
| Covid-19 | D000086382 | — | U07.1 | — | — | 1 | — | — | 1 |
| Respiratory insufficiency | D012131 | — | J96.9 | — | — | 1 | — | — | 1 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | 1 | — | — | 1 |
| Syndrome | D013577 | — | — | — | — | 1 | — | — | 1 |
| Overweight | D050177 | — | E66.3 | — | — | 1 | — | — | 1 |
| Death | D003643 | PATO_0001422 | — | — | — | 1 | — | — | 1 |
| Left ventricular dysfunction | D018487 | — | — | — | — | 1 | — | — | 1 |
| St elevation myocardial infarction | D000072657 | — | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Weight loss | D015431 | — | — | — | 2 | — | — | — | 2 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 2 | — | — | — | 2 |
| Diastolic heart failure | D054144 | EFO_1000899 | I50.30 | — | 1 | — | — | — | 1 |
| Asymptomatic diseases | D058070 | — | — | — | 1 | — | — | — | 1 |
| Hyperuricemia | D033461 | — | — | — | 1 | — | — | — | 1 |
| Exercise | D015444 | EFO_0000483 | — | — | 1 | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 10 | — | — | — | — | 10 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 1 | 1 |
| Diabetic cardiomyopathies | D058065 | EFO_1001458 | — | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 1 | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | — | 1 | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | — | — | — | 1 | 1 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 1 | 1 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 1 | 1 |
| Acute kidney injury | D058186 | — | N17 | — | — | — | — | 1 | 1 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dapagliflozin |
| INN | dapagliflozin |
| Description | Dapagliflozin is a C-glycosyl comprising beta-D-glucose in which the anomeric hydroxy group is replaced by a 4-chloro-3-(4-ethoxybenzyl)phenyl group. Used (in the formo f its propanediol monohydrate) to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. It has a role as a hypoglycemic agent and a sodium-glucose transport protein subtype 2 inhibitor. It is a C-glycosyl compound, an organochlorine compound and an aromatic ether. |
| Classification | Small molecule |
| Drug class | phlorozin derivatives, phenolic glycosides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 461432-26-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL429910 |
| ChEBI ID | 85078 |
| PubChem CID | 9887712 |
| DrugBank | DB06292 |
| UNII ID | 1ULL0QJ8UC (ChemIDplus, GSRS) |
Target
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Variants
No data
Financial
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Forxiga – Bristol Myers Squibb
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Farxiga – AstraZeneca
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Qtern – AstraZeneca
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Estimated US medical usage
Dapagliflozin
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Dapagliflozin and metformin hydrochloride, Xigduo
Adverse Events
Top Adverse Reactions
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32,251 adverse events reported
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